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PERUCONPLASMA: Evaluating the Use of Convalescent Plasma as Management of COVID-19

Primary Purpose

COVID-19

Status
Completed
Phase
Phase 2
Locations
Peru
Study Type
Interventional
Intervention
Convalescent plasma
Sponsored by
Universidad Peruana Cayetano Heredia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for COVID-19 focused on measuring COVID-19, Convalescent plasma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Hospitalized 18 years old or older patient with COVID-19 disease, confirmed by a molecular test or a serologic test, along with a typical COVID-19 clinical presentation.

  • Severe or critical disease caused by COVID-19 Severe disease is defined as 2 or more of the following criteria:

    • Respiratory frequency >22
    • O2 saturation ≤93%
    • PaO2 50mmHg
    • PaO2/FiO2 <300

  • Or critical disease with one or more of the following criteria:

    • Respiratory insufficiency with requirement of mechanical ventilation within the last 72hours
    • Shock
  • Inform consent signed by patient or direct family member.

Exclusion Criteria:

  • Contraindication for transfusion (history of TRALI or TACO, history of anaphylaxis to blood components
  • Multiorgan failure, defined by a SOFA score of >5
  • hemodynamically unstable, with mean arterial pressure <60 mmHg, refractory to vasopressors use
  • Uncontrolled concomitant infection
  • Disseminated intravascular coagulation
  • Myocardial infarction
  • Acute coronary disease
  • Patient on dialysis
  • Intracranial bleeding active within the last 7 days
  • Pregnancy

Sites / Locations

  • Hospital Cayetano Heredia
  • Hospital Nacional Hipolito Unanue

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Experimental group

Control group

Arm Description

Administration of 1 to 2 units of convalescent plasma (200 ml to 250 ml, each), within 48 hours, plus standard of care.

Standard of care

Outcomes

Primary Outcome Measures

Transfusion-related Serious Adverse Events
Incidence of transfusion-related Serious Adverse Events, according to the Hemovigilance Module Surveillance Protocol v2.5.2

Secondary Outcome Measures

All-cause in-hospital mortality
Death during hospitalization within the first 30 days after enrollment
Length of hospital stay
Number of days from date of enrollment to date of discharge
Length of ICU stay
Number of days from date of admission to the ICU to date of discharge from ICU
Need of invasive mechanical ventilation
Requirement of invasive mechanical ventilation (Yes/No). Evaluated only for those participants that were on non-invasive ventilatory support at time of randomization
Duration of mechanical ventilation
Number of days from date of intubation to date of successful extubation
Clinical Improvement at 14 days
Improvement of 2 or more points in the WHO progression scale

Full Information

First Posted
July 31, 2020
Last Updated
October 20, 2021
Sponsor
Universidad Peruana Cayetano Heredia
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1. Study Identification

Unique Protocol Identification Number
NCT04497324
Brief Title
PERUCONPLASMA: Evaluating the Use of Convalescent Plasma as Management of COVID-19
Official Title
PERUCONPLASMA: Randomized Clinical Trial to Evaluate Safety and Efficacy of the Use of Convalescent Plasma in Hospitalized Patients With COVID-19
Study Type
Interventional

2. Study Status

Record Verification Date
March 2021
Overall Recruitment Status
Completed
Study Start Date
September 21, 2020 (Actual)
Primary Completion Date
April 17, 2021 (Actual)
Study Completion Date
April 17, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Universidad Peruana Cayetano Heredia

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Open label controlled clinical trial to evaluate the safety and efficacy of the use of convalescent plasma in hospitalized patients with COVID-19 infection. This study will have two arms, one arm will receive convalescent plasma plus standard of care, and the other arm will receive standard of care only. Adults older than 18 years old, hospitalized with diagnosis of COVID-19 confirmed by a laboratory test (molecular or serology), with severe or life-threatening disease, will be included to the study after obtaining inform consent by the patient of a direct family member. Participants will be then randomized 1:1 to the experimental and the control groups. Participants at the experimental group will receive 1 to 2 units of ABO compatible COVID-19 convalescent plasma (200 ml to 250 ml each) within 48 hours, in addition to the standard of care. Participants at the control group will receive standard of care. Safety of convalescent plasma administration will be evaluated, as well as other indicators of clinical efficacy.
Detailed Description
The study protocol can be found in: https://trialsjournal.biomedcentral.com/articles/10.1186/s13063-021-05189-6

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COVID-19
Keywords
COVID-19, Convalescent plasma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Experimental group
Arm Type
Experimental
Arm Description
Administration of 1 to 2 units of convalescent plasma (200 ml to 250 ml, each), within 48 hours, plus standard of care.
Arm Title
Control group
Arm Type
No Intervention
Arm Description
Standard of care
Intervention Type
Biological
Intervention Name(s)
Convalescent plasma
Intervention Description
Administration of 1 to 2 units of convalescent plasma (200 ml to 250 ml, each), within 48 hours, plus standard of care.
Primary Outcome Measure Information:
Title
Transfusion-related Serious Adverse Events
Description
Incidence of transfusion-related Serious Adverse Events, according to the Hemovigilance Module Surveillance Protocol v2.5.2
Time Frame
14 days after randomization
Secondary Outcome Measure Information:
Title
All-cause in-hospital mortality
Description
Death during hospitalization within the first 30 days after enrollment
Time Frame
30 days after randomization
Title
Length of hospital stay
Description
Number of days from date of enrollment to date of discharge
Time Frame
30 days after randomization or until hospital discharge, whatever comes first
Title
Length of ICU stay
Description
Number of days from date of admission to the ICU to date of discharge from ICU
Time Frame
30 days after randomization or until hospital discharge, whatever comes first
Title
Need of invasive mechanical ventilation
Description
Requirement of invasive mechanical ventilation (Yes/No). Evaluated only for those participants that were on non-invasive ventilatory support at time of randomization
Time Frame
30 days after randomization or until hospital discharge, whatever comes first
Title
Duration of mechanical ventilation
Description
Number of days from date of intubation to date of successful extubation
Time Frame
30 days after randomization or until hospital discharge, whatever comes first
Title
Clinical Improvement at 14 days
Description
Improvement of 2 or more points in the WHO progression scale
Time Frame
At 3, 14 and 30 days after randomization

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Hospitalized 18 years old or older patient with COVID-19 disease, confirmed by a molecular test or a serologic test, along with a typical COVID-19 clinical presentation. Severe or critical disease caused by COVID-19 Severe disease is defined as 2 or more of the following criteria: Respiratory frequency >22 O2 saturation ≤93% PaO2 50mmHg PaO2/FiO2 <300 Or critical disease with one or more of the following criteria: Respiratory insufficiency with requirement of mechanical ventilation within the last 72hours Shock Inform consent signed by patient or direct family member. Exclusion Criteria: Contraindication for transfusion (history of TRALI or TACO, history of anaphylaxis to blood components Multiorgan failure, defined by a SOFA score of >5 hemodynamically unstable, with mean arterial pressure <60 mmHg, refractory to vasopressors use Uncontrolled concomitant infection Disseminated intravascular coagulation Myocardial infarction Acute coronary disease Patient on dialysis Intracranial bleeding active within the last 7 days Pregnancy
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Fiorella Krapp Lopez, MD, MSc
Organizational Affiliation
Universidad Peruana Cayetano Heredia
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Patricia Garcia Funegra, MD, MSc
Organizational Affiliation
Universidad Peruana Cayetano Heredia
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital Cayetano Heredia
City
Lima
ZIP/Postal Code
15102
Country
Peru
Facility Name
Hospital Nacional Hipolito Unanue
City
Lima
Country
Peru

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
34001174
Citation
Soto A, Krapp F, Vargas A, Cabrejos L, Argumanis E, Garcia PL, Altamirano K, Montes M, Chacon-Uscamaita PR, Garcia PJ. Randomized clinical trial to evaluate safety and efficacy of convalescent plasma use among hospitalized patients with COVID-19 (PERUCONPLASMA): a structured summary of a study protocol for a randomized controlled trial. Trials. 2021 May 17;22(1):342. doi: 10.1186/s13063-021-05189-6.
Results Reference
derived

Learn more about this trial

PERUCONPLASMA: Evaluating the Use of Convalescent Plasma as Management of COVID-19

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